Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clopidogrel
Kent Pharmaceuticals Ltd
B01AC04
Clopidogrel
75mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02090000; GTIN: 5060061160650 5060061160773
PACKAGE LEAFLET: INFORMATION FOR THE USER GREPID 75 MG FILM-COATED TABLETS clopidogrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4. WHAT IS IN THIS LEAFLET 1. What Grepid is and what it is used for 2. What you need to know before you take Grepid 3. How to take Grepid 4. Possible side effects 5. How to store Grepid 6. Contents of the pack and other information 1. W HAT G REPID IS AND WHAT IT IS USED FOR Grepid contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis). Grepid is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack or death). You have been prescribed Grepid to help prevent blood clots and reduce the risk of these severe events because: - you have a condition of hardening of arteries (also known as atherosclerosis), and - you have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial infarction’ (heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You should Read the complete document
OBJECT 1 GREPID (CLOPIDOGREL) 75MG TABLETS X 30 Summary of Product Characteristics Updated 30-Apr-2014 | Beacon Pharmaceuticals 1. Name of the medicinal product Grepid 75 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 75 mg of clopidogrel (as besilate). Excipients with known effect: Each film-coated tablet contains 2.47 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Pink, round, biconvex, film-coated tablets. 4. Clinical particulars 4.1 Therapeutic indications _Prevention of atherothrombotic events_ Clopidogrel is indicated in: • Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. • Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. _Prevention of atherothrombotic and thromboembolic events in atrial fibrillation_ In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1. 4.2 Posology and method of administration Posology • Adults and older people Clopidogrel should be given as a single daily dose of 75 mg. In patients suffering from acute coronary syndrome: − Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-w Read the complete document